Study to Investigate the Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset-Suppressing Effect and Safety of ONO-2910 in Patients With Breast Cancer Receiving Weekly Paclitaxel

An Early Phase II, Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Comparison Study to Investigate the Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset-Suppressing Effect and Safety of ONO-2910 in Patients With Breast Cancer Receiving Weekly Paclitaxel

To investigate the safety and CIPN onset-suppressing effect of ONO-2910 in participants receiving paclitaxel (PTX) weekly as chemotherapy for breast cancer in Japan.

Study Overview

• Status: Completed
• Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Intervention / Treatment: Drug: ONO-2910; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Fujita Health University Hospital
  • Aichi, Japan
    • Nagoya City University Hospital
  • Aichi, Japan
    • Nagoya University Hospital
  • Chiba, Japan
    • National Cancer Center Hospital East
  • Chiba, Japan
    • Funabashi Municipal Medical Center
  • Chiba, Japan
    • Medical Corporation Tesshokai Kameda Medical Center
  • Fukuoka, Japan
    • Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
  • Gunma, Japan
    • Gunma Prefectural Cancer Center
  • Ibaraki, Japan
    • University of Tsukuba Hospital
  • Kagoshima, Japan
    • Social Medical Corporation Hakuaikai Sagara Hospital
  • Kanagawa, Japan
    • Tokai University Hospital
  • Kanagawa, Japan
    • Nippon Medical School Musashikosugi Hospital
  • Kumamoto, Japan
    • Kumamoto University Hospital
  • Kumamoto, Japan
    • Kumamoto Shinto General Hospital
  • Okayama, Japan
    • Okayama University Hospital
  • Okinawa, Japan
    • Nahanishi Clinic
  • Osaka, Japan
    • Osaka University Hospital
  • Osaka, Japan
    • Osaka Breast Clinic
  • Osaka, Japan
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Osaka, Japan
    • Osaka Rosai Hospital
  • Osaka, Japan
    • Yodogawa Christian Hospital
  • Saitama, Japan
    • Saitama Medical University International Medical Center
  • Saitama, Japan
    • Japanese Saitama Red Cross Hospital
  • Shizuoka, Japan
    • Shizuoka General Hospital
  • Tokyo, Japan
    • National Cancer Center Hospital
  • Tokyo, Japan
    • Nippon Medical School Hospital
  • Tokyo, Japan
    • St. Luke's International Hospital
  • Tokyo, Japan
    • Toranomon Hospital
  • Tokyo, Japan
    • Center Hospital of the National Center for Global Health and Medicine
  • Tokyo, Japan
    • Tokyo Metropolitan Komagome Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with ECOG Performance Status 0 or 1
2. Patients scheduled to receive 12 consecutive weekly doses of PTX (80 mg/m2, intravenous infusion) as a perioperative treatment of clinical stage I-III breast cancer (concomitant use of trastuzumab and pertuzumab is allowed)
3. Patients who meet the following organ functions according to the laboratory test results at the time of treatment registration.However, blood transfusions and measurements within 7 days after administration of granulocyte colony-stimulating factor (G-CSF) are excluded.

Neutrophil count >= 1,500/mm3, Platelet count >= 75,000/mm3, Hemoglobin >= 10.0 g/dL or >= 6.2 mmol/L, Serum creatinine <= 2.0 mg/dL, Total bilirubin <= 3.0 mg/dL, ALT and AST <= 100 IU/L or less than 2.5 times the facility's upper limit of clinical laboratory test values

Exclusion Criteria:

1. Patients with grade 1 or higher peripheral sensory neuropathy, peripheral motor neuropathy, or extremity edema in the upper or lower extremities.
2. Patients with pain or numbness in the upper or lower extremities due to a history/complication, such as stroke, diabetic neuropathy, alcoholic neuropathy, carpal tunnel syndrome, tarsal tunnel syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Fisher syndrome, knee osteoarthritis, hernia, cervical spondylosis, lumbar spondylosis, spinal canal stenosis, peripheral circulatory disorders, hand-foot syndrome,etc.
3. Patients who have difficulty in evaluating limb symptoms due to trauma/defects in the upper or lower limbs, or complications such as infectious or inflammatory diseases on the skin of the upper or lower limbs.
4. Patients with concurrent multiple cancers.
5. Patients who have not recovered from toxicity (Grade 1 or less) from prior treatment.
6. Patients who have been administered platinum agents, bortezomib, vinca alkaloids, and taxanes including PTX in the past, and patients who are scheduled to be administered these drugs other than PTX during the study period.
7. Prior treatment other than trastuzumab or pertuzumab (chemotherapy, molecular targeted drug therapy, antibody therapy, hormone therapy, immunotherapy, radiation therapy, etc.) within 7 days before the start of the treatment period (Visit 2) (including the start date of the treatment period) ) was performed.
8. At the beginning of the treatment phase (Visit 2), Patients using peripheral neuropathic pain medications such as pregabalin, mirogabalin, duloxetine, tricyclic and tetracyclic antidepressants, gabapentin, analgesics such as loxoprofen and acetaminophen, vitamin B12 such as mecobalamin, chinese herbal medicines indicated for pain such as goshajinkigan, and opioids such as oxycodone.
9. Patients who plan to receive preventive compression therapy (surgical gloves, elastic stockings, etc.) or preventive cooling therapy for chemotherapy-induced limb adverse events during the study period
10. Patients scheduled for surgery during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo Tablet will be orally administered once daily.
Experimental: ONO-2910	Drug: ONO-2910; ONO-2910 Tablet will be orally administered once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy evaluation：Proportion of participants with peripheral sensory neuropathy (NP)# of Grade 2 or higher by 12 weeks after the start of intervention	12 week
Number of Participants with AE	Up to 101 days
Weight	Up to 87 days
body temperature	Up to 87 days
pulse rate	Up to 87 days
blood pressure	Up to 87 days
ECG heart rate	Up to 87 days
ECG RR interval	Up to 87 days
ECG PR interval	Up to 87 days
ECG QRS complex	Up to 87 days
ECG QT interval	Up to 87 days
ECG QTcF	Up to 87 days
Hematology	Up to 87 days
Clinical chemistry	Up to 87 days
Blood coagulation	Up to 87 days
Urinalysis	Up to 87 days
Pregnancy test	Up to 101 days
Viral test	baseline

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): September 19, 2024
• Study Completion (Actual): September 19, 2024

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: ONO-2910-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No